FDA.reportPublic FDA data

IPS

Primary DI
00888118142382
Brand
IPS
Company
KLS-Martin L.P.
Model
60-500-29-09-LP
Device description
SPLINT, ALTERNATE, FINAL, FREEPRINT ORTHO, LP
Published
2023-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118142382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118142382008881181423828881181423820888118142382

GMDN Terms#

Term, Definition table
TermDefinition
Fixed dental occlusal splint, custom-madeA rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, typically in the perioperative period after trauma or orthognathic surgery (surgical orthodontics). It is fixed to the teeth with ligature wires by a clinician and is intended to remain in place short-term (<=30 days) until sufficient bone healing has taken place. The device is manufactured to meet the needs of an individual patient. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154934LEVEL ONE CMF25-874-15-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351235TRUMATCHMaterialise NVJEY2026-10-22
05420060351235TRUMATCHMaterialise NVDZJ2026-10-22
05420060351242TRUMATCHMaterialise NVDZJ2026-10-22
05420060351242TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVJEY2026-10-22
05420060351259TRUMATCHMaterialise NVDZJ2026-10-22
05420060351266TRUMATCHMaterialise NVJEY2026-10-22
05420060351266TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVDZJ2026-10-22
05420060351273TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVJEY2026-10-22
05420060351280TRUMATCHMaterialise NVDZJ2026-10-22
05420060351297TRUMATCHMaterialise NVJEY2026-10-22
05420060351297TRUMATCHMaterialise NVDZJ2026-10-22
05420060351303TRUMATCHMaterialise NVDZJ2026-10-22
05420060351303TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVJEY2026-10-22
05420060351310TRUMATCHMaterialise NVDZJ2026-10-22
05420060351327TRUMATCHMaterialise NVJEY2026-10-22
05420060351327TRUMATCHMaterialise NVDZJ2026-10-22
05420060351334TRUMATCHMaterialise NVJEY2026-10-22
05420060351334TRUMATCHMaterialise NVDZJ2026-10-22
05420060351341TRUMATCHMaterialise NVJEY2026-10-22
05420060351341TRUMATCHMaterialise NVDZJ2026-10-22
05420060351358TRUMATCHMaterialise NVJEY2026-10-22
05420060351358TRUMATCHMaterialise NVDZJ2026-10-22
05420060351365TRUMATCHMaterialise NVDZJ2026-10-22
05420060351365TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVJEY2026-10-22
05420060351372TRUMATCHMaterialise NVDZJ2026-10-22